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Clinical Trial Details

Trial ID: L4222
Source ID: NCT01416324
Associated Drug: Placebo
Title: First Time in Human Study Using GSK2330672
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: placebo|DRUG: 0.1 mg GSK2330672|DRUG: 0.3 mg GSK2330672|DRUG: 1 mg GSK2330672|DRUG: 3 mg GSK2330672|DRUG: 10 mg GSK2330672|DRUG: 30 mg GSK2330672|DRUG: 60 mg GSK2330672
Outcome Measures: Primary: Change in vital signs, frequency and absolute value change in heart rate, blood pressure, respiration rate relative to placebo, 1, 2, 4, 8, 12, 24, 48 hours|ECGs relative to placebo, frequency of clinically significant changes in 12-lead ECG parameters relative to placebo, 1, 2, 4, 8, 12, 24, 48 hours|Changes in clinical lab results, Changes in clinical chemistry, hematology, urinalysis results relative to placebo, 24 hours|lung function tests, Measure changes in FEV, FVC, FEF 25-75%, PEFR relative to placebo, 1, 3, 8, 24 hours|Adverse events relative to placebo, Frequency and severity of adverse events relative to placebo, 48 hour monitoring | Secondary: Measurement of the maximum concentration (Cmax) for study drug, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours|Measurement of the time to achieve maximum concentration (tmax) for study drug, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours|Measurement of area under the curve (AUC) for study drug, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours|Measurement of half life (t 1/2) of study drug, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours|Measurement of apparent clearance (CL/F) of the study drug, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours|Measurement of the apparent volume of distribution (V/F) of the study drug, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours
Sponsor/Collaborators: Sponsor: GlaxoSmithKline
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 17
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2011-06-15
Completion Date: 2011-09-09
Results First Posted:
Last Update Posted: 2017-06-20
Locations: GSK Investigational Site, Minneapolis, Minnesota, 55404, United States
URL: https://clinicaltrials.gov/show/NCT01416324